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DECONEX IR

Dosage form: tablet
Ingredients: Guaifenesin 380mg, Phenylephrine Hydrochloride 10mg
Labeler: Poly Pharmaceuticals
NDC Code: 50991-716

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DECONEX IR TABLETS

Drug Facts Active ingredients
(in each tablet)

Guaifenesin 380 mg
Phenylephrine HCl 10 mg

PurposeExpectorant
Nasal Decongestant

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passage

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions Do not exceed recommended dosage.
Adults and children
12 years of age and over:
1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours.
Children 6 to under 12
years of age:
1/2 tablet every 4 hours, not to
exceed 3 tablets in 24 hours.
Children under
6 years of age:
Consult a physician.


Other informationStore at controlled room temperature between 15°- 30°C (59°- 86°F).
Supplied in a tight, light-resistant container with a child-resistant cap.
Contains color additives including FD&C Yellow No. 5 (tartrazine).
Deconex IR Tablets are green, oval-shaped, scored tablets, debossed "POLY" bisect "716" on one side, and plain on the other side.

Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.

Questions? Comments?Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355
1 (800) 882-1041

Rev. 02/12

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-716-60

DECONEX IR
TABLETS


EXPECTORANT · NASAL DECONGESTANT

Each tablet contains:
Guaifenesin..............................380 mg
Phenylephrine HCl......................10 mg

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Distributed by:
Poly Pharmaceuticals
Quitman, MS  39355

60 tablets

Rev.  02/12






DECONEX  IR
guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-716
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin380 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Hypromelloses 
Maltodextrin 
Povidone 
Silicon Dioxide 
Cellulose, Microcrystalline 
Stearic Acid 
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodePOLY;716
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-716-6060 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/25/2012
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(50991-716)

Revised: 10/2012
 
Poly Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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